Efficacy of Polypodium Leucotomos Extract Decreasing UVA Premutagenic and Photoaging Markers

With this study, the investigators will like to determine if taking a dose of the study medication, called Polypodium leucotomos (PL), prevents some of the changes in the skin caused by the adverse effects of UVA, a type of ultraviolet light.

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Key information

Conditions

Aging Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami Skin Research Group Office

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects,
18 years of age or older,
with Fitzpatrick skin types II and III.

Exclusion criteria

Pregnancy
Personal history of skin cancer
History of abnormal photosensitivity
Smokers
Patients with history or being exposed to other forms of radiation (other than sunlight)
History or current exposure to asbestos
Patients taking any drug that might alter the response of skin to UVR (including, but are not limited to, doxycycline, sulfas, psoralens, and amiodarone)
Patients unable to undergo skin biopsies
History of abnormal scarring
History of adverse reaction to local anesthesia

Treatment and study plan

Polypodium Leucotomos

Drug

Subject is given a 7.5 mg/kg oral dose of Polypodium leucotomos during Baseline visit, and again at 8 hours and 2 hours before the Follow-up visit #2.

Other names: Heliocare

Primary outcomes

Change in Common Deletion (CD) Value in DNA of Skin Biopsy Sample

Time frame: baseline, 24 hours

CD is determined by semiquantitative real-time polymerase chain reaction.
8-oxo-7,8-dihydro-2'-Deoxyguanosine (8-oxo-dG) Quantification in Skin Biopsy Sample Taken From Final Visit

Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Single-Blind Study Determining the Efficacy of Polypodium Leucotomos Extract Supplement in Decreasing UVA Premutagenic and Photoaging Markers

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Aug 27, 2007
Registry last updated: Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed